Tag Archives: gene editing

Explore the Possibilities and Challenges of Biotechnology

Fundamental, emerging, and applied life science and biotechnology research are critical to the bioeconomy, science, health, agriculture, energy, the environment, and national security and defense. The biotechnology economy is growing rapidly, with the scale, scope, and complexity of products increasing. Our titles address critical, emerging policy and technical issues associated with the life sciences and biotechnology research and their applications.

Physics of Life

Physics of Life

Biological physics, or the physics of living systems, has emerged fully as a field of physics, alongside more traditional fields of astrophysics and cosmology, atomic, molecular and optical physics, condensed matter physics, nuclear physics, particle physics, and plasma physics. This new field brings the physicist’s style of inquiry to bear on …[more]

Heritable Human Genome Editing

Heritable Human Genome Editing

Heritable human genome editing – making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy – raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have …[more]

Safeguarding the Bioeconomy

Safeguarding the Bioeconomy

Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to …[more]

Forest Health and Biotechnology: Possibilities and Considerations

Forest Health and Biotechnology: Possibilities and Considerations

The American chestnut, whitebark pine, and several species of ash in the eastern United States are just a few of the North American tree species that have been functionally lost or are in jeopardy of being lost due to outbreaks of pathogens and insect pests. New pressures in this century are putting even more trees at risk. Expanded human …[more]

Biodefense in the Age of Synthetic Biology

Biodefense in the Age of Synthetic Biology

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly …[more]

Human Genome Editing: Science, Ethics, and Governance

Human Genome Editing: Science, Ethics, and Governance

Genome editing is a powerful new tool for making precise alterations to an organism’s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve …[more]

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise …[more]

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to …[more]

Genetically Engineered Crops: Experiences and Prospects

Genetically Engineered Crops: Experiences and Prospects

Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the …[more]

New Frontiers of Biomedical Science: Possibilities and Issues

Credit: American Cancer Institute

As scientific advances have made genome editing and other biomedical technologies more efficient, precise, and flexible than ever before, scientists, patients, and others have been exploring possible ways in which this cutting-edge science can improve human health. Our titles consider both the potential benefits and the scientific, ethical, legal, social, and governance issues associated with the use of gene-editing tools and other new technologies. As always, all are free to read online or download.

The Emerging Field of Human Neural Organoids, Transplants, and Chimeras: Science, Ethics, and Governance

The Emerging Field of Human Neural Organoids, Transplants, and Chimeras: Science, Ethics, and Governance

Each year, tens of millions of individuals in the U.S. suffer from neurological and psychiatric disorders including neurodegenerative diseases such as Alzheimer’s Disease and Parkinson’s Disease, and psychiatric disorders such as autism spectrum disorder, depression and schizophrenia. Treatments for these diseases are often completely …[more]

Next Steps for Functional Genomics: Proceedings of a Workshop

Next Steps for Functional Genomics: Proceedings of a Workshop

One of the holy grails in biology is the ability to predict functional characteristics from an organism’s genetic sequence. Despite decades of research since the first sequencing of an organism in 1995, scientists still do not understand exactly how the information in genes is converted into an organism’s phenotype, its physical …[more]

Heritable Human Genome Editing

Heritable Human Genome Editing

Heritable human genome editing – making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy – raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have …[more]

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop

Sharing knowledge is what drives scientific progress – each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings …[more]

Safeguarding the Bioeconomy

Safeguarding the Bioeconomy

Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to …[more]

Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies: A Synthesis of Relevant National Academies Reports

Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies: A Synthesis of Relevant National Academies Reports

Over the past 15 years, the National Academies of Sciences, Engineering, and Medicine (the National Academies) have convened multiple committees of leading experts to address ethical challenges related to innovative and emerging biomedical technologies. After reviewing prior National Academies’ reports, individual ethics principles and …[more]

Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop–in Brief

Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop–in Brief

On November 27-29, 2018, the U.S. National Academy of Sciences and U.S. National Academy of Medicine, the Royal Society of the United Kingdom, and the Academy of Sciences of Hong Kong convened the Second International Summit on Human Genome Editing at the University of Hong Kong. The summit brought together more than 500 researchers, ethicists, …[more]

Understanding Disparities in Access to Genomic Medicine: Proceedings of a Workshop

Understanding Disparities in Access to Genomic Medicine: Proceedings of a Workshop

Genomic medicine is defined as the routine use of genomic information about an individual as part of his or her clinical care as well as the health outcomes and policy implications of that clinical use. It is one approach that has the potential to improve the quality of health care by allowing practitioners to tailor prevention, diagnostic, and …[more]

Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop

Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop

Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of …[more]

Human Genome Editing: Science, Ethics, and Governance

Human Genome Editing: Science, Ethics, and Governance

Genome editing is a powerful new tool for making precise alterations to an organism’s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve …[more]

International Summit on Human Gene Editing: A Global Discussion

International Summit on Human Gene Editing: A Global Discussion

New biochemical tools have made it possible to change the DNA sequences of living organisms with unprecedented ease and precision. These new tools have generated great excitement in the scientific and medical communities because of their potential to advance biological understanding, alter the genomes of microbes, plants, and animals, and treat …[more]

The Science and Applications of Microbial Genomics: Workshop Summary

The Science and Applications of Microbial Genomics: Workshop Summary

Over the past several decades, new scientific tools and approaches for detecting microbial species have dramatically enhanced our appreciation of the diversity and abundance of the microbiota and its dynamic interactions with the environments within which these microorganisms reside. The first bacterial genome was sequenced in 1995 and took …[more]

The Future of Biotechnology – Guiding Change to Advance Science

Advances in science, new actors, economic investments, and societal challenges and concerns will all influence new types of biotechnology products in development. These publications explore possibilities, obstacles, and societal considerations as we experience changes in the scope, scale, complexity, and tempo of biotechnology products. All are free to read or download.

Safeguarding the Bioeconomy

Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the …

[more]

Forest Health and Biotechnology: Possibilities and Considerations

The American chestnut, whitebark pine, and several species of ash in the eastern United States are just a few of the North American tree species that have been functionally lost or are in jeopardy of being lost due to outbreaks of pathogens and …

[more]

The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through

Since the end of the Second World War, the United States has developed the world’s preeminent system for biomedical research, one that has given rise to revolutionary medical advances as well as a dynamic and innovative business sector …

[more]

Biodefense in the Age of Synthetic Biology

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and …

[more]

Preparing for Future Products of Biotechnology

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of …

[more]

Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies

The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing …

[more]

Genetically Engineered Crops: Experiences and Prospects

Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human …

[more]

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as …

[more]

Industrialization of Biology: A Roadmap to Accelerate the Advanced Manufacturing of Chemicals

The tremendous progress in biology over the last half century – from Watson and Crick’s elucidation of the structure of DNA to today’s astonishing, rapid progress in the field of synthetic biology – has positioned us for significant innovation in …

[more]

Positioning Synthetic Biology to Meet the Challenges of the 21st Century: Summary Report of a Six Academies Symposium Series

Synthetic biology — unlike any research discipline that precedes it — has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope …

[more]

Convergence: Facilitating Transdisciplinary Integration of Life Sciences, Physical Sciences, Engineering, and Beyond

Convergence of the life sciences with fields including physical, chemical, mathematical, computational, engineering, and social sciences is a key strategy to tackle complex challenges and achieve new and innovative solutions. However, …

[more]

Sequencing the Human Genome – Applications, Ethics, and Implications

In honor of National DNA Day, explore new technologies and treatments that have resulted from the sequencing of the human genome and their ethical, medical, and societal implications. As always, our publications are free to read online or download.

Human Genome Editing: Science, Ethics, and Governance

Genome editing is a powerful new tool for making precise alterations to an organism’s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an …

[more]

Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop–in Brief

On November 27-29, 2018, the U.S. National Academy of Sciences and U.S. National Academy of Medicine, the Royal Society of the United Kingdom, and the Academy of Sciences of Hong Kong convened the Second International Summit on Human Genome …

[more]

International Summit on Human Gene Editing: A Global Discussion

New biochemical tools have made it possible to change the DNA sequences of living organisms with unprecedented ease and precision. These new tools have generated great excitement in the scientific and medical communities because of their …

[more]

The Promise of Genome Editing Tools to Advance Environmental Health Research: Proceedings of a Workshop—in Brief

Advances in genome editing – the process for making precise additions, deletions, and alterations of DNA and RNA – have opened the door for studying biological mechanisms of health and disease. On January 10-11, 2018, the National Academies of …

[more]

Biodefense in the Age of Synthetic Biology

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and …

[more]

Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations

Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child …

[more]

The Economics of Genomic Medicine: Workshop Summary

The sequencing of the human genome and the identification of links between specific genetic variants and diseases have led to tremendous excitement over the potential of genomics to direct patient treatment toward more effective or less harmful …

[more]

Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary

Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology is the summary of a workshop convened in May 2012 by the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy of the …

[more]

Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary

The number of new drug approvals has remained reasonably steady for the past 50 years at around 20 to 30 per year, while at the same time the total spending on health-related research and development has tripled since 1990. There are many …

[more]

Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary

The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic …

[more]

Integrating Large-Scale Genomic Information into Clinical Practice: Workshop Summary

The initial sequencing of the human genome, carried out by an international group of experts, took 13 years and $2.7 billion to complete. In the decade since that achievement, sequencing technology has evolved at such a rapid pace that today a …

[more]

Direct-to-Consumer Genetic Testing: Summary of a Workshop

Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this …

[more]

Evolution of Translational Omics: Lessons Learned and the Path Forward

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using …

[more]

Mapping and Sequencing the Human Genome

There is growing enthusiasm in the scientific community about the prospect of mapping and sequencing the human genome, a monumental project that will have far-reaching consequences for medicine, biology, technology, and other fields. But how will …

[more]

Human Gene Editing: The Issues Behind the Progress in Genetics

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A major component of the National Academy of Sciences and the National Academy of Medicine’s Human Gene-Editing Initiative was the International Summit on Human Gene Editing that took place this past week. Co-hosted with the Chinese Academy of Sciences and the U.K.’s Royal Society, the summit convened experts from around the world to discuss the scientific, ethical, and governance issues associated with human gene-editing research. The Summit Statement is available here, and the video and slides of the Summit will be permanently available at the summit website.

Below is a list of our titles that were either directly mentioned in presentations, or are related to this topic. All are free to download.

2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research (2008)


ISBN 978-0-309-12220-7

In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national …

[more]

Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop (2015)


ISBN 978-0-309-36783-7

On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called …

[more]

Biotechnology Research in an Age of Terrorism (2004)


ISBN 978-0-309-08977-7

In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or …

[more]

Globalization, Biosecurity, and the Future of the Life Sciences (2006)


ISBN 978-0-309-10032-8

Biomedical advances have made it possible to identify and manipulate features of living organisms in useful ways&#8212leading to improvements in public health, agriculture, and other areas. The globalization of scientific and technical expertise …

[more]

Improving the Efficiency and Effectiveness of Genomic Science Translation: Workshop Summary (2014)


ISBN 978-0-309-29453-9

The process for translating basic science discoveries into clinical applications has historically involved a linear and lengthy progression from initial discovery to preclinical testing, regulatory evaluation and approval, and, finally, use in …

[more]

Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary (2014)


ISBN 978-0-309-30168-8

Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive …

[more]

A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National Research Council and the American Association for the Advancement of Science (2009)


ISBN 978-0-309-12510-9

The same technologies that fuel scientific advances also pose potential risks–that the knowledge, tools, and techniques gained through legitimate biotechnology research could be misused to create biological weapons or for bioterrorism. This is …

[more]

Challenges and Opportunities for Education About Dual Use Issues in the Life Sciences (2010)


ISBN 978-0-309-15840-4

The Challenges and Opportunities for Education About Dual Use Issues in the Life Sciences workshop was held to engage the life sciences community on the particular security issues related to research with dual use potential. More than 60 …

[more]

Diplomacy for the 21st Century: Embedding a Culture of Science and Technology Throughout the Department of State (2015)


ISBN 978-0-309-37313-5

Diplomacy for the 21st Century recommends steps that the Department of State should embrace to take full advantage of the leading science and technology (S&T) capabilities of the United States. These capabilities provide the department …

[more]

Public Engagement on Genetically Modified Organisms: When Science and Citizens Connect: A Workshop Summary (2015)


ISBN 978-0-309-37421-7

The National Research Council’s Roundtable on Public Interfaces of the Life Sciences held a 2-day workshop on January 15-16, 2015, in Washington, DC to explore the public interfaces between scientists and citizens in the context of genetically …

[more]

Trust and Confidence at the Interfaces of the Life Sciences and Society: Does the Public Trust Science? A Workshop Summary (2015)


ISBN 978-0-309-37792-8

Does the public trust science? Scientists? Scientific organizations? What roles do trust and the lack of trust play in public debates about how science can be used to address such societal concerns as childhood vaccination, cancer screening, and …

[more]

Improving Genetics Education in Graduate and Continuing Health Professional Education: Workshop Summary (2015)


ISBN 978-0-309-31605-7

Many health care providers do not have either the knowledge or the tools they need in order to apply genetic information in their day-to-day practices. This lack of support is contributing to a substantial delay in the translation of genetic …

[more]

The Value of Genetic and Genomic Technologies: Workshop Summary (2010)


ISBN 978-0-309-15771-1

Knowing one’s genetic disposition to a variety of diseases, including common chronic diseases, can benefit both the individual and society at large. The IOM’s Roundtable on Translating Genomic-Based Research for Health held a workshop on March …

[more]

Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary (2015)


ISBN 978-0-309-37112-4

The inclusion of genomic data in a knowledge-generating health care system infrastructure is one promising way to harness the full potential of that information to provide better patient care. In such a system, clinical practice and research …

[more]

Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary (2014)


ISBN 978-0-309-30494-8

Rapid advances in technology have lowered the cost of sequencing an individual’s genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic …

[more]

Integrating Large-Scale Genomic Information into Clinical Practice: Workshop Summary (2012)


ISBN 978-0-309-22034-7

The initial sequencing of the human genome, carried out by an international group of experts, took 13 years and $2.7 billion to complete. In the decade since that achievement, sequencing technology has evolved at such a rapid pace that today a …

[more]

Assessing Genetic Risks: Implications for Health and Social Policy (1994)


ISBN 978-0-309-08660-8

Raising hopes for disease treatment and prevention, but also the specter of discrimination and “designer genes,” genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of …

[more]

Emerging and Readily Available Technologies and National Security: A Framework for Addressing Ethical, Legal, and Societal Issues (2014)


ISBN 978-0-309-29334-1

Emerging and Readily Available Technologies and National Security is a study on the ethical, legal, and societal issues relating to the research on, development of, and use of rapidly changing technologies with low barriers of entry that …

[more]